Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children

• Status: Not yet recruiting
• Trial end date: 2028-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The MATIC-2 is a multicenter clinical trial enrolling children who are less than 18 years of age with hemorrhagic shock potentially needing significant blood transfusion.

The primary objective of the clinical trial is to determine the effectiveness of Low Titer Group O Whole Blood (LTOWB) compared to component therapy (CT), and Tranexamic Acid (TXA) compared to placebo in decreasing 24-hour all-cause mortality in children with traumatic life threatening hemorrhage.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Philip Spinella
• Collaborator: Biomedical Advanced Research and Development Authority
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

1. Children, defined as less than 18 years of age with traumatic injury

2. MTP activation for confirmed or suspected active life-threatening traumatic bleeding

AND

Confirmed or suspected active life-threatening traumatic bleeding with at least 2 of 3 of the following criteria:

1. Hypotension for age (< 5% tile)

2. Tachycardia for age (>95th % tile)

3. Traumatic injury with exam findings consistent with severe bleeding (e.g., penetrating injury, hemothorax, distended abdomen with bruising, amputation of limb).

Exclusion Criteria:

1. Unknown time of injury

2. Greater than 3 hours since time of injury

3. History of seizure after the injury event

4. Known allergy or hypersensitivity reaction to TXA

5. Comatose (Glasgow Coma Score of 3) with fixed and dilated pupils suggesting nonsurvivable brain injury

6. MTP activated but no blood products given

7. Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving randomized blood products)

8. Patients who are obviously pregnant on clinical examination

9. Known prisoners as defined in protocol

10. Known ward of the state

11. Isolated hanging, drowning or burns

12. Previous enrollment in MATIC-2

13. Prior study opt-out with bracelet